Kelly Wilkerson Email and Phone Number
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I am a highly motivated, detail-oriented, clinical research professional with over 20 years of experience in global clinical operations, working with top pharmaceutical and biotech companies in the industry.My core competencies include overseeing the performance and management of clinical research studies, sites, strategic partners, and vendors, ensuring ICH-GCP compliance, patient safety, and data integrity. I also excel at developing and executing clinical operations and recruitment strategies, identifying and mitigating risks, analyzing and interpreting data and trends, resolving data and site issues, and improving study performance metrics. I have a proven track record of innovation, collaboration, and leadership, with expertise in oncology and other therapeutic areas. Additionally, I am passionate about fostering diversity, equity, and inclusion (DEI) in clinical trials, and have created and implemented diversity-focused initiatives aimed at promoting inclusivity and representation within clinical trials, as well as served as a diversity subject matter expert (SME). My mission is to deliver high-quality data and effective clinical operations for innovative therapies that improve lives for people of all races, identities, and socioeconomic backgrounds.
Otsuka Pharmaceutical Companies (U.S.)
View- Website:
- otsuka-us.com
- Employees:
- 3622
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Senior Manager, Clinical ManagementOtsuka Pharmaceutical Companies (U.S.)United States
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Associate Director, Clinical Operations, Clinical Research LiaisonSeres Therapeutics May 2021 - PresentCambridge, Massachusetts, UsProvide oversight for vendor operational activities (e.g., site and study management, monitoring, UATs, issues escalations).• Determined study risks and implemented mitigations; set Key Quality Indicators and Key Risk Indicators; conducted issue escalations; and assessed data, Key Performance Indicator analytics, and trends, resulting in improved data and adherence to compliance standards.• Proactively proposed innovative ideas that mitigated potential challenges for cross-functional development teams. • Executed inspection readiness activities and root cause analysis, addressed internal process audit findings, and spearheaded resolution initiatives (including creation of Corrective and Preventative Actions (CAPAs)), resulting in expedited FDA approval of company's first marketed product.• Create recruitment plans, guides, and outreach content to boost diversity recruitment and engage in discussions to understand subject recruitment challenges and offer potential solutions. -
Associate Director, Site Monitoring OversightBoehringer Ingelheim May 2019 - May 2021Ingelheim Am Rhein, Rhineland-Palatinate, DeProvide Sponsor oversight of study sites, CRO, and clinical research vendors and define and establish thresholds for KPI, KQI, KRI, and other targeted operational metrics along with mappings to processes and roles.• Catalyzed improved performance, enhanced study oversight, and increased accuracy and reporting of study metrics through execution of comprehensive cross-functional risk mitigation plans, strategies, and CAPAs.• Revamped internal tools and streamlined global and departmental processes within first 6 months of employment.• Impacted the development of clinical protocols and amendments; database structure; clinical plans, strategies, and guidelines. -
Senior Clinical Trial ManagerPrecision Oncology . Sep 2018 - Apr 2019Flemington, Nj, UsDeveloped detailed clinical plans and guidelines that improved the creation of study-related documents, including protocols and amendments. Successfully delivered and managed study engagement, from start-up to close-out activities, ensuring seamless execution.• Collaborated with functional team members to ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned clinical trial(s). -
Lead, Regional Clinical LeadTesaro, Inc. Apr 2017 - Sep 2018Waltham, Massachusetts, UsOversaw 31 study sites, 15 CRAs, and multiple external vendors.• Improved data metrics compliance by 55% and decreased safety event reporting by 40% in 8 months through risk identification and process improvements.• Championed diversity enrollment and enrichment efforts to attract broad patient populations.• Developed recruitment strategy to increase recruitment of diverse populations. -
Lead Cra/Cra Line ManagerEcog-Acrin Cancer Research Group Sep 2016 - Apr 2017Philadelphia, Pa, Us• Mentored an interdisciplinary team of 15 Clinical Research Associates in streamlining monitoring processes,identifying risks, and executing mitigations to enhance data quality. -
Personal Goal PursuitCareer Break Apr 2015 - Aug 2016
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Senior Clinical Site Manager, Lead Clinical Site ManagerGenentech Jan 2007 - Mar 2015South San Francisco, California, Us• Advocated for diversity in clinical trial recruitment and coached study teams on the social determinants of health for underrepresented populations.• Increased clinical trial diversity by working with teams to create targeted patient recruitment and retention tools.• Co-designed a mobile IT platform that reduced report completion time by 28 minutes, and enhanced efficiency, data quality, and issue management.• Exceeded initial enrollment projections by 50%.• Established Indiana territory.• Oversaw onsite, remote, and Risk-Based Monitoring for phase I - IV clinical trials in Oncology, CNS - Mood Disorders, Internal Medicine, and Endocrinology. -
Business LeadGenentech Jun 2011 - Nov 2013South San Francisco, California, Us• Created and obtained approval from the Sr. VP, Global Head, Development, Innovation, and Clinical Operations for a $530K business plan for the iPad project.• Co-developed a mobile IT platform that interfaced with CTMS that resulted in improved efficiency, better use of resource time, and improved data quality and issue management.• Co-wrote and performed the UAT scripts.• Reduced monitoring report completion time by 28 min. per report, thus improving monitoring reporting metrics and reducing future resourcing costs.• Influenced the alignment of business strategies that promoted the widespread implementation of suitable clinical trial technologies supporting the global monitoring network.
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Lead It Super UserGenentech 2007 - 2010South San Francisco, California, Us• Directed and managed the Super User Working Group.• Improved quality, productivity, effectiveness, and efficiency of business processes. • Created and obtained approval for a $200K business plan that decreased operating cost of field monitors by eliminated the need for external printing services.• Re-designed and standardized trip report templates and company business forms and processes.• Created Monitoring Visit Report Guidelines and instructional manuals and provided the associated training.
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Senior Lead Clinical Research AssociateAnaclim Jun 2006 - Oct 2006Us• Established and maintained strategic partnerships to promote and increase the company’s visibility among leading cardiology experts and thought leaders.• Identified pathways and sources to recruit, cultivate and engage diverse investigators and sites that serve diverse patient populations.• Liaised with physicians to assess research sites and gather insights on barriers to diversifying clinical trial participation.• Facilitated budget negotiations and contracted with investigational sites and vendors. -
Clinical Research Site ManagerPfizer Jun 2005 - May 2006New York, New York, Us• Organized and performed activities in the evaluation, initiation, monitoring, and closeout of investigative sites. • Identified key training needs and mentored junior associates.• Conducted training sessions (e.g. workshops, train-the-trainer, awareness sessions).• Oncology Subject Matter Expert -
Regional Clinical Research AssociateSanofi Apr 2001 - Jun 2005Paris, France, Fr• Monitored phase II - IV Oncology, CNS, Internal Medicine, and Endocrinology clinical trial sites. • Networked with physicians, principal investigators, research directors, and site staff regarding clinical and medical concepts in protocols and other documents. -
In-House Clinical Research AssociateEli Lilly And Company Jan 2000 - Apr 2001Indianapolis, Indiana, Us• Led escalation meetings for GCP non-compliant investigators being reported to the FDA.• Performed Quality Control/Auditing Visits to identify egregious site performance issues. -
Regional Clinical Research Monitor (Consultant)Eli Lilly And Company 1997 - 2000Indianapolis, Indiana, UsMonitored the compliance of multiple Oncology drug studies and CNS drug studies including mood disorders, ALS and Parkinson’s with FDA regulations.
Kelly Wilkerson Skills
Kelly Wilkerson Education Details
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University Of PittsburghBiology (Vertebrate Anatomy/Development And Animal Behavior)
Frequently Asked Questions about Kelly Wilkerson
What company does Kelly Wilkerson work for?
Kelly Wilkerson works for Otsuka Pharmaceutical Companies (U.s.)
What is Kelly Wilkerson's role at the current company?
Kelly Wilkerson's current role is Senior Manager, Clinical Management.
What is Kelly Wilkerson's email address?
Kelly Wilkerson's email address is ke****@****eim.com
What is Kelly Wilkerson's direct phone number?
Kelly Wilkerson's direct phone number is +131791*****
What schools did Kelly Wilkerson attend?
Kelly Wilkerson attended University Of Pittsburgh.
What skills is Kelly Wilkerson known for?
Kelly Wilkerson has skills like Clinical Trials, Pharmaceutical Industry, Oncology, Instructional Design, Training, It Solutions, Biotechnology, Gcp, Clinical Research, Formatting Documents, Cross Functional Team Leadership, Fda.
Who are Kelly Wilkerson's colleagues?
Kelly Wilkerson's colleagues are Tom Desmond, Brent Treadway, Alicia Banks, Pharmd, Rph, Pacs, Edward Whitcomb, Vishal Parvadiya, Mitch Johnston, Baron Harness.
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